GCSF in Alcoholic Hepatitis

NCT03703674 | Unknown Phase 4 DMC

• 1 other identifier: GCSF IN ALCOHOLIC HEPATITIS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Alcoholic hepatitis is related to very high mortality rate. About 40% of the patients are died within first 6 months after the detection of the clinical syndrome. Therefore, it is very essential for proper diagnosis and early treatment. In response to acute or chronic liver damage, bone marrow derived stem cells can spontaneously populate liver and differentiate into hepatic cells. Animal and human studies suggested that injured hepatocyte may be replaced by pluripotent bone marrow cells. However, this hepatocyte repopulation is highly dependent on varieties of liver injury and therapeutic conditions. The studies has suggested Granulocyte-colony stimulating factors (G-CSF) can regenerate hepatocyte by fusing with hematopoietic cells, thereby enhancing the liver histology and survival rate. G-CSF is a cytokine capable to regulate a number of functions in neutrophils. In three recent studies mobilization of bone marrow stem cells induced by G-CSF was observed in patients with alcoholic hepatitis. In two of this studies there was a survival benefit with the use of G-CSF. Therefore we plan to study the safety and efficacy of G-CSF in the patients with alcoholic hepatitis.

Conditions

Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (1)

• Survival at 3 months

  90 DAYS

Secondary Outcomes (5)

• Mobilisation of CD34 positive cells in peripheral blood.

  6 DAYS

• Improvement in MELD score

  90 DAYS

• Improvement in Maddrey's Discriminant Function.

  90 Days

• Improvement in Child Turcotte Pugh score.

  90 Days

• Number of participants with treatment-related adverse events in the different groups.

  90 Days

Study Arms (2)

Standard Medical Therapy

ACTIVE COMPARATOR

Drug: standard medical therapy Standard medical therapy involves primary treatment and normal hospital nutrition (1800 to 2000 kcal per day). Diuretics, sodium restriction and albumin for treatment of ascites or fresh frozen plasma for coagulopathy or antibiotics for any focus of infection as spontaneous bacterial peritonitis (SBP), pneumonia, cellulitis, and urinary tract infection as indicated.

Drug: GCSF

G-CSF + Standard Medical Therapy

EXPERIMENTAL

Drug: standard medical therapy Standard medical therapy involves primary treatment and normal hospital nutrition (1800 to 2000 kcal per day). Diuretics, sodium restriction and albumin for treatment of ascites or fresh frozen plasma for coagulopathy or antibiotics for any focus of infection as spontaneous bacterial peritonitis (SBP), pneumonia, cellulitis, and urinary tract infection as indicated. Drug: G-CSF G-CSF- 5 μg/Kg s.c every 12 hours for 5 consecutive days

Drug: GCSF

Interventions

GCSF DRUG

Granulocyte-colony stimulating factors (G-CSF)

G-CSF + Standard Medical Therapy; Standard Medical Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alcoholic hepatitis patients:
• More than 10 years of heavy alcohol consumption (mean intake ≈ 100 g/day).
• Elevated aspartate aminotransferase level (but \<500 IU per millilitre) and Ratio ofAST/ALT≥2 times
• Elevated serum total bilirubin level ≥ 5 mgdL (86 μmol/L)
• Elevated INR(≥1.5) and
• Neutrophilia. Patient with Maddrey's DF of ≥ 32 will be included in the study, with or without biopsy.

You may not qualify if:

• \. Age \< 18 and \> 75 years 2. Hepatocellular carcinoma or portal vein thrombosis 3. Refusal to participate in the study 4. Serum creatinine\>1.0 mg% 5. Hepatic encephalopathy- grade 3 or 4 6. Upper gastrointestinal bleed in last ten days 7. Uncontrolled bacterial infection 8. Human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus seropositivity, Autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency 9. Pregnancy 10. Glucocorticoid treatment 11. Significant co-morbidity 12. Previous known hypersensitivity to G-CSF

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Hepatitis, Alcoholic

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Central Study Contacts

Virendra Singh, DM

CONTACT

7087009338; virendrasingh100@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Hepatology

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 12, 2018
• Study Start: November 19, 2017
• Primary Completion: November 18, 2020
• Study Completion: November 18, 2020
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)